| CTRI Number |
CTRI/2022/04/042052 [Registered on: 21/04/2022] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to Evaluate the Safety and Efficacy of Herbal /Nutraceutical Oral Capsule and Herbal / Nutraceutical Rectal Medication Combination in Improving the Gut Health of Patients with Type 2 Diabetes Having Chronic Kidney Disease (CKD). |
|
Scientific Title of Study
|
A Prospective, Randomized, Open label, Parallel group, Comparative Clinical Trial to Evaluate the Safety and Efficacy of Herbal / Nutraceutical Oral Capsule and Herbal / Nutraceutical Rectal Medication Combination in Improving the Gut Health of Patients Receiving Standard of Care Treatment for Type 2 Diabetes Having Chronic Kidney Disease (CKD). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GH-CKD/2022/01 Version 1.0 dated 10 Mar 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr C Devanpally |
| Designation |
Managing Director |
| Affiliation |
Ardent Clinical Research Services |
| Address |
Office-305, 309, Level-3, West Wing, Nyati Unitree
Yerwada.
Pune
MAHARASHTRA
411006
India |
| Phone |
9545817447 |
| Fax |
- |
| Email |
cdevanpally@ardent-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr C Devanpally |
| Designation |
Managing Director |
| Affiliation |
Ardent Clinical Research Services |
| Address |
Office-305, 309, Level-3, West Wing, Nyati Unitree,
Yerwada.
Pune
MAHARASHTRA
411006
India |
| Phone |
9545817447 |
| Fax |
- |
| Email |
cdevanpally@ardent-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr C Devanpally |
| Designation |
Managing Director |
| Affiliation |
Ardent Clinical Research Services |
| Address |
Office-305, 309, Level-3, West Wing, Nyati Unitree,
Yerwada.
Pune
MAHARASHTRA
411006
India |
| Phone |
9545817447 |
| Fax |
- |
| Email |
cdevanpally@ardent-cro.com |
|
|
Source of Monetary or Material Support
|
| Arogyaseva Medical Academy of India (AMAI)
Office Sr. No. 8/4/1, Yashwant Apt. Shope No. 7, Lane no. 4, Karve nagar, Pune, Maharashtra 411052, INDIA |
|
|
Primary Sponsor
|
| Name |
Arogyaseva Medical Academy of India AMAI |
| Address |
Office Sr. No. 8/4/1, Yashwant Apt. Shope No. 7, Lane no. 4, Karve nagar, Pune, Maharashtra 411052, INDIA |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amit Bhate |
Bhate Hospital |
Bhate hospital,CTS.No.4830/13/14 1st Floor, Dr. Ambedkar Rd Opp. Civil Hospital Belgavi, 590002
Belgaum
KARNATAKA |
8197940086
-
amitbhate85@gmail.com |
| Dr Jay Soni |
Parth Hospital |
E 405/4, 407-411,
Fourth Floor Galaxy Arcade, Near Galaxy Cinema, Naroda, Gujarat 382330
Ahmadabad
GUJARAT |
9898003433
-
drjaysonicr@gmail.com |
| Dr Pavan Wakhare |
Saikrupa Hospital |
Sai Krupa Hospital First floor Plot 4/14/B sector 34, renuka corner, tapkir chowk,thergaon pune 411033
Pune
MAHARASHTRA |
7719016069
-
Pavannephro14@gmail.com |
| Dr Jayesh Waghulde |
Signus Hospital |
Signus Hospital, fifth floor general ward research department Near Atul Diary Rd, Pathardi gaon, Pathardi phata, Nasik 422010
Nashik
MAHARASHTRA |
9922251176
-
jayeshpwaghulde@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ethiclin Pvt. Ltd Independent Ethics Committee |
Approved |
| Institutional ethics committee Sai Krupa Hospital |
Approved |
| Muktai Hospital Institutional Ethics Committee |
Approved |
| Parth Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E112||Type 2 diabetes mellitus with kidney complications. Ayurveda Condition: Type 2 diabetes with CKD, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Ayurvedic Capsule, Reference: NA, Route: Oral, Dosage Form: Taila, Dose: 445(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: In the intervention arm along with the Capsule, 60 ml of ayurvedic oil will be administered to the patients through rectum. Oil will be administered once a day and after every 3 days for the duration of 90 days. | | 2 | Comparator Arm (Non Ayurveda) | | - | Standard of care treatment | As per PI descrition |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
i.Adult male and non-pregnant females aged 18 to 65 years
ii.Patients who have weak gut health characterized by either constipation or diarrhea (more than 2 episodes per day in the past 5 days)
iii.Patients who are diabetic with CKD non-dialysis will be considered in the study.
iv.Able to comply with all required study procedures and schedule.
v.Able to comply and willing to follow the prescribed diet plan.
vi.Willing and able to give written informed consent.
|
|
| ExclusionCriteria |
| Details |
i.Patient on antibiotics or vitamin supplement (except vitamin D analogs) in the last three months.
ii.Advanced liver disease, advanced cardiovascular disease, heart failure with EF < 30%, and autoimmune disease.
iii.The use of chemotherapy, antibiotics, immunosuppressive medications, probiotics, and steroid in the last three month.
iv.Intravenous or oral iron supplementation, laxatives, and kayexalate in the last month.
v.History of intra-abdominal surgery, small or large intestine resection or small bowel obstruction.
vi.History of colon cancer or gastrointestinal bleed.
vii.Patient who has participated in a clinical study within the last 30 days prior to entering this study.
viii.Patients with hypersensitivity to any of the ingredients of the study products.
ix.Patients who are taking immunosuppressive therapy.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
i. Change in Abdominal pain scale from baseline to end of the treatment.
ii. Average scores of gastrointestinal symptoms by questionnaire from
baseline to end of the treatment. |
Baseline to end of the treatment.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i. Changes or % incidence of adverse events, laboratory test results, vital signs between the groups from their screening visit to end of treatment.
ii. Percentage (%) change in the TNF alpha ILF, IL8 between the groups from their screening visit to end of treatment.
iii. Percentage (%) change in the pathogenic microbiome (fecal) between the groups from their screening visit to end of treatment.
iv. Percentage (%) change in the non-pathogenic microbiome (fecal) between the groups from their screening visit to end of treatment.
v. Changes in the uremic metabolites (uric acid, creatinine) between the groups from their screening visit to end of treatment.
vi. Percentage (%) change in the associated symptoms of uremia between the groups from their screening visit to end of treatment. |
Baseline to End of the treatment |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/05/2022 |
| Date of Study Completion (India) |
21/07/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A prospective, randomized, open
label, parallel group, comparative clinical trial to evaluate the safety and
efficacy of Ayurvedic oral capsule and Ayurvedic anal oil combination (an
ayurvedic formulation) in improving the gut health of patients receiving
standard of care treatment for type2 diabetes having chronic kidney disease
(CKD). This trial is designed to asses the safety and efficacy of an Ayurvedic capsule to improve the Gut health of Type 2 diabetes patients with CKD disease. Total 90 patients will be randomized in 1: 1 ratio, 45 patients in each arm. One group will receive Ayurvedic capsule + SOC and remaining patients will receive only SOC as per randomization number assigned to each eligible patient. |